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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP/Guideline study with acceptable restrictions: - no data on purity of the test substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive application of the test substance).
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: Lab sample
- Storage: room temperature
- Physical state: solid, insoluble in water
- Stability: guaranteed by sponsor
- Safety precautions: gloves and face masks

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Further description: KFM-NZW
- Source: Kleintierfarm, Madoerin AG, CH-4414, Fuellindorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2000 - 2050 g (within ± 20% of mean value)
- Fasting period before study: no
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland (Routine analysis of the diet for nutritive contents and for contamination indicated no significant deviations expected to influence the study outcome);
- Water: ad libitum (Routine analysis for contamination indicated no significant deviations expected to influence the study outcome).
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours after removing the gauze patches.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² (flanks).
- Type of wrap if used: gauze patch (20 cm²) carrying the test substance covered with aluminium foil (36 cm²) and held in place adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data.

SCORING SYSTEM: OECD scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Very slight erythema was seen (score 1) at the 1 and 24 hour-observation.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Very slight erythema was seen (score 1) at the 1 and 24 hour-observation.
Irritation parameter:
edema score
Basis:
mean
Remarks:
(animal # 1, 2 and 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Very slight edema was seen (score 1) in 2 animals at the 1-hour observation. The effect was fully reversible by the 24 hour observation.

Any other information on results incl. tables

Table 1: Body weights at the start and after 3 days (end)

Animal no.

1

2

3

At start

2050 g

2000 g

2000 g

After 3 days

2150 g

2010 g

2020 g

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met